Metabolic Syndrome and Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Pasquale Pignatelli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01882114
First received: May 24, 2013
Last updated: June 17, 2013
Last verified: June 2013

May 24, 2013
June 17, 2013
November 2007
June 2013   (final data collection date for primary outcome measure)
Prevalence of metabolic syndrome in anticoagulated nonvalvular atrial fibrillation patients [ Time Frame: At baseline ] [ Designated as safety issue: No ]
To assess the prevalence of metabolic syndrome in a population of patients suffering from nonvalvular atrial fibrillation receiving oral anticoagulants. The relationship between metabolic syndrome and vascular events will be described. Vascular events included a composite outcome of fatal and non fatal acute myocardial infarction, acute fatal and non fatal ischemic stroke, cardiac revascularization (stent/cabg), cardiovascular death.
Same as current
Complete list of historical versions of study NCT01882114 on ClinicalTrials.gov Archive Site
  • Progression of atherosclerosis in non valvular atrial fibrillation patients receiving oral anticoagulant therapy. [ Time Frame: One year ] [ Designated as safety issue: No ]
    To assess the progression of atherosclerosis in nonvalvular atrial fibrillation patients defined by some surrogate markers. In particular ankle brachial index, intima media thickness, flow mediated dilation and transthoracic echocardiogram will be performed to all enrolled patients.
  • Analysis of oxidative stress markers in atrial fibrillation [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Oxidative stress markers such as plasmatic and urinary isoprostanes, thromboxane, platelet recruitment, reactive species of oxygen, nadph oxidase(nox2)will be measured. Differences of these markers among patients experiencing or not a vascular outcome will be described
  • Changing in glomerular filtration rate of anticoagulated patients with non valvular atrial fibrillation [ Time Frame: One year ] [ Designated as safety issue: No ]
    To assess changes in renal function after one year of follow up in patients with non valvular atrial fibrillation receiving oral anticoagulants
  • Determinants of Time in Therapeutic Range [ Time Frame: Patients will be followed for an expected mean time of 25 months ] [ Designated as safety issue: No ]
    To assess the determinants of time in therapeutic range (TTR) in patients receiving oral anticoagulants
  • Use of digoxin in atrial fibrillation [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Use of digoxin will be assessed at baseline. The relationship with vascular outcomes will be described
  • Echocardiographic characteristics in patients with paroxysmal or persistent/permanent atrial fibrillation [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Transthoracic echocardiography will be performed at baseline. Morphologic and functional measures will be registered. The relationship with vascular outcome will be described
Same as current
Mediterranean diet adherence in non valvular atrial fibrillation [ Time Frame: At baseline ] [ Designated as safety issue: No ]
To assess the adherence to the mediterranean diet in patients receiving oral anticoagulants
Same as current
 
Metabolic Syndrome and Atrial Fibrillation
Impact of Metabolic Syndrome on Atrial Fibrillation Outcomes

The prevalence of metabolic syndrome in patients suffering from non valvular atrial fibrillation is derived from studies regarding recurrences of atrial fibrillation after catheter ablation. Prospective studies in european countries are stil lacking. Furthermore the impact of metabolic syndrome on cardiovascular events in patients with non valvular atrial fibrillation is still unknown.

Atrial fibrillation (AF) is the most common cardiac arrhythmia that is associated with a high risk of cardiovascular events and increased morbidity and mortality. Cardiovascular events are prevalently localized in the cerebral circulation in which AF is responsible for ischemic stroke. Clinical characteristics of ischemic stroke from AF are almost severe and thromboembolism is considered the most important cause. Thus, ischemic stroke is deemed to origin from thrombus formation generated in the left atrium with ensuing embolism in the cerebral circulation.

Patients with AF are typically associated with different risk factors of atherothrombosis including, overall, hypertension which may be detected in about 70-80% of the population; other risk factors are diabetes and dyslipidemia. This accounts for instrumental evidence of systemic atherosclerosis associated to AF. Thus, signs of atherosclerosis have been detected in the thoracic aorta, as represented by aortic plaque assessed by trans-esophageal echocardiography; patients with complex aortic plaque had fourfold increased rate of stroke compared to plaque-free patients.

Metabolic syndrome (MetS) is a constellation of atherosclerotic risk factors including, according to the modified National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII), hypertension, low HDL, impaired glycaemic control, hypertriglyceridemia and central obesity as assessed by waist circumference; the presence of MetS is associated with an increased risk of developing cardiac and cerebral ischemic events.

An higher risk to develop atrial fibrillation (AF) has been well recognized in patients with MetS. In a prospective, community-based, observational cohort study with annual health check-up 28449 subjects without AF the age-adjusted rates of AF were higher in subjects with compared to those without metabolic syndrome during a mean follow-up of 4.5 years.

Few studies reported on the prevalence of MetS in AF population are still lacking. Some data can be inferred from studies regarding recurrence of AF after catheter ablation reporting a prevalence ranging from 18.8% to 49.4% . The only population study so far published included 741 chinese patients and reported a prevalence of the MetS in AF of 46.3%. Taking into account the different thresholds of waist circumferences recommended by international societies for different ethnic groups, it is unclear if such prevalence can be extrapolated to population of western countries. Furthermore the impact of MetS on the incidence of cardiovascular events in patients with non valvular AF (NVAF) taking oral anticoagulant therapy (OAT) has never been investigated.

Therefore, our aim has been to investigate the prevalence of MetS in a population of NVAF patients under oral coagulation treatment and its impact on cardiovascular events during a prospective study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

After overnight fasting and supine rest for at least 10 minutes, blood was withdrawn from the antecubital vein. Serum was divided into aliquots and stored at -80°C.

Non-Probability Sample

Prospective single-center study included 896 consecutive patients with NVAF who referred to our center for monitoring and management of antithrombotic therapies of the Department of Internal Medicine and Medical Specialties of Sapienza-University of Rome between November 2007 and April 2013.

  • Atrial Fibrillation
  • Metabolic Syndrome
  • Oxidative Stress
  • Atherosclerosis
  • Disorders, Blood Coagulation
Not Provided
Not Provided
Pastori D, Carnevale R, Cangemi R, Saliola M, Nocella C, Bartimoccia S, Vicario T, Farcomeni A, Violi F, Pignatelli P. Vitamin E serum levels and bleeding risk in patients receiving oral anticoagulant therapy: a retrospective cohort study. J Am Heart Assoc. 2013 Oct 28;2(6):e000364. doi: 10.1161/JAHA.113.000364.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 2030
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • non valvular atrial fibrillation
  • age >18 years
  • any antithrombotic treatment

Exclusion Criteria:

  • prosthetic heart valves, or the presence of any severe valvulopathies, severe congestive heart failure (NYHA functional class IV), severe cognitive impairment, chronic infectious (HIV, hepatitis C, HBV) or autoimmune systemic disease. Furthermore, subjects were excluded from the study if they had active neoplastic diseases or liver insufficiency (eg, cirrhosis).
Both
18 Years and older
Yes
Italy
 
NCT01882114
MetS1306/2007
Yes
Pasquale Pignatelli, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Study Director: Francesco Violi, Prof Sapienza Università di Roma
University of Roma La Sapienza
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP